Anda di halaman 1dari 1

46

Feature Interview

Innovations in EP:
Interview with Greg Cash
Interview by Jodie Elrod

labs at UCLA Cardiac Arrhythmia


Center with Dr. Kalyanam Shivkumar
n this interview, EP Lab Digest and his team. Valuable guidance has
speaks with Greg Cash about the been provided by Dr. Mauricio Arruda
proprietary PURE EP technology from UH Case Medical Center in
platform, designed to improve the Cleveland. Clinical input has also
clinical outcomes of electrophysiology been provided by Dr. Vivek Reddy
procedures. Greg Cash is the President from Mount Sinai Hospital in New
and CEO of BioSig Technologies, Inc., York, Dr. David Haines from William
located in Los Angeles, California.
Beaumont Hospital in Michigan, and
Dr. Hiroshi Nakagawa from the Heart
What is the PURE EP System?
Rhythm Institute at the University of
The PURE EP System is a mul- Oklahoma.
tichannel electrocardiog ram and
intracardiac EP recording platform. How does the proprietary
It is designed to allow for precise, un- PURE EP System compare
interrupted, real-time evaluations of with conventional EP recording
electrocardiograms and electrograms systems currently available?
during electrophysiology procedures What disadvantages are there in
ranging from simple diagnostic tests to current EPrecording systems?
catheter ablation for the most complex
The PURE EP System preserves the
cases of arrhythmias.
patients cardiac signal morphology
by minimizing non-biologic signals
How was the PURE EP System
such as noise, artifacts, and baseline
developed? Tell us about
wander through digital signal processits concept validation and
ing. Existing systems, many of which
technology development.
employ core technology nearly 20 years
The PURE EP System has been de- old, are unable to eliminate electrical
veloped with the input of leading car- interference without compromising
diac electrophysiologists from around signal quality.
the country. Initial concept discussions
were held with Drs. Andrea Natale In what ways can the
and Luigi Di Biase at Texas Cardiac PUREEPSystem help improve
Arrhythmia Institute (TCAI); proof of ablation procedures?
concept, as well as prototype testing,
The technology employed in the
were carried out at the EP and animal PURE EP System was designed to

PURE EP represents a significant technological advance in the EP information and recording system segment, and provides the potential to improve patient
outcomes as well as decrease procedure times.
MARCH 2015

BioSig.indd 46

allow electrophysiologists to obtain


signals morphology currently masked
by noise, such as early activation and
late potentials in the case of ventricular
tachycardia, and various atrial signals in the case of atrial fibrillation.
Theoretically, this should allow for
more precise ablation.

The next steps involve the Mayo


Clinic and UCLA animal studies and
first-in-human studies at TCAI, followed by multicenter studies at leading
arrhythmia centers. FDA approval to
market could come as early as this
time next year.

Can you share some of the


How have procedure times been history of BioSig Technologies?
affected using this system?
What brought you to the
This has yet to be validated; how- company?
ever, the system employs confidence
BioSig was co-founded in 2009 by
indexes aimed at improving procedural Ken Londoner, a serial entrepreneur
efficiency by eliminating the need for in the medical technology field and
multiple maneuvers and retrospective former mutual fund manager in New
data validation.
York, and a team of biomedical engineers with expertise in biomedical
In what ways does the PURE
signal processing. I joined the company
EP System help workload and
for several reasons I believe PURE
patient outcomes in the EP lab? EP represents a significant technoWhen validated, the software features logical advance in the EP informaand confidence indexes could result tion and recording system segment,
in time reduction of EP studies and and provides the potential to improve
ablation procedures, thereby increasing patient outcomes as well as decrease
lab throughput. In terms of outcomes, procedure times; electrophysiology is
the potential exists to improve success one of the few medical device markets
rates by identifying further ablation enjoying double-digit growth; and, we
targets, in addition to anatomically have a world-class scientific advisory
based procedures such as the pulmo- board featuring many of the leading
nary vein isolation approach for atrial electrophysiologists in the field.
fibrillation ablation.
Disclosure: As disclosed in the article,
What studies are taking place
Mr. Cash is the President & CEO of
using the PURE EP System?
BioSig Technologies, Inc.
We are planning animal studies
with Drs. Samuel Asirvatham and K.L. CALL FOR AUTHORS!
Venkatachalam at the Mayo Clinic
in Rochester as well as with Dr. We are currently looking for
Shivkumar at UCLA in Los Angeles.
authors to write for upcoming
The clinical plan for human studies is
issues. If you would be interested
currently under development.
in contributing an article,

What are the next steps? How


soon could we see approval and
commercialization of the PURE
EP System?

WWW.EPLABDIGEST.COM

please contact Managing


Editor Jodie Elrod at: jelrod@
hmpcommunications.com

EP LAB DIGEST

2/25/15 1:54 PM